Johnson & Johnson suspended worldwide sale of its device used in fibroid surgery amid concerns over its potential to spread undetected cancer beyond the uterus.
The company said it is suspending the sale of its power morcellators until their role in fibroid treatment is better understood and redefined by the medical community.
The action follows a Food and Drug Administration advisory on April 17 that discouraged doctors from using laparoscopic power morcellators to remove fibroids because of a risk of worsening an often-hidden cancer. (r.reuters.com/dug68v)
"Ethicon morcellation devices have always included cautions in their instructions for use about the potential spread of malignant tissue," J&J wrote in a letter to customers, a copy of which is available with Reuters.
J&J said the step was not a product removal as the FDA maintained that power morcellation may still be the best option for some patients after risk evaluation and informed consent.
The FDA was not immediately available for comment outside regular U.S. business hours.
"We are also reaching out to regulatory agencies around the globe as this is a global notification," J&J spokeswoman Sheri Woodruff told Reuters.
Laparoscopic power morcellation is one of several available treatments for fibroids. It is a procedure that uses a medical device to divide the uterine tissue into smaller pieces or fragments so it can be removed through a small incision in the abdomen.
Uterine fibroids are non-cancerous growths that originate from the smooth muscle tissue in the wall of the uterus.
(Reporting by Supriya Kurane and Arnab Sen in Bangalore; Editing by Gopakumar Warrier)